Molecules / Alprostadil

Alprostadil API manufacturers

CAS 745-65-3 ATC C01EA01 Updated 9 July 2026
6
manufacturers with an active filing 5 of them hold a US DMF or a CEP
44
shortage records on file across 10 countries
209
finished-dose makers across 40 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

EUROAPI

Hungary
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs and one valid CEP for alprostadil, filing since 1994. Its 2019 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2019 · NAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
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03

TIEN (Tianjin) Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for alprostadil, filing since 2020. Its 2017 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2017 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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04

Cayman Pharma Sro

Czech Republic
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for alprostadil, filing since 1992.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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05

Maruishi Pharmaceutical

Japan
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for alprostadil, filing since 2013.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Registered with SFDA (Saudi Arabia) for alprostadil. Its GMP is recognised in 4 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
4 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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3 more manufacturers hold filings for alprostadil

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Cayman Pharma SroMaruishi PharmaceuticalChinoin Pharmaceutical And Chemical Works
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Contract manufacturers (5)

Zhejiang Ausun Pharmaceutical China Lgm Pharma United States Vem Ilac Sanayi Ve Ticaret A S Turkey Everlight Chemical Ind Taiwan Shenzhen Haorui Industrial Dev China

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (18)

Pfizer Brasil Ltda Brazil Pfizer United States HIKMA ITALIA Italy Viatris United States Pfizer Italia Italy Pfizer Manufacturing Belgium Belgium Casen Recordati, S.L Spain Pfizer Manufacturing Belgium Nv, Puurs, Belgica Belgium Solupharm Pharmazeutische Erzeugnisse Germany Swiss Parenterals India Altan Pharmaceuticals Spain Chiesi Farmaceutica Ltda Brazil Groupe Parima Canada Mylan Dublin Ireland GEBRO PHARMA Austria Laboratorios Fada Pharma Argentina Neon Laboratories India Pfizer Canada Ulc Canada

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

Who makes alprostadil?

Ask Fred which manufacturers are on record for alprostadil and what filings they hold.

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Also on this molecule

Shortages 44 Recalls 44 Finished dose 18 Contract mfrs 5